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You’ve been searching for a safer weight loss device solution that gives you meaningful weight loss without restricting your food choices and lifestyle. Now it’s here. A new approach to weight loss. Mike, vBloc ® Patient of vBloc patients in a feasibility study were able to maintain, decrease or discontinue their diabetes medications while achieving improved glycemic control at 12 months. 3 Improved LDL cholesterol levels Lowered triglycerides Lowered blood pressure Lowered heart rate Reduced waist circumference Patients who lost weight with vBloc: 4 Patients who used vBloc ® Therapy maintained their weight loss longer than those who did not. 2 average excess weight loss experienced in one year when vBloc was used for 12 hours per day 1 more weight loss than patients who did not receive vBloc Therapy 2 Effective Treatment What kind of weight loss can you expect? Meaningful Weight Loss Lose weight, gain health.

A new approach to weight loss. - MedStar Health · A new approach to weight loss. Mike, vBloc ® Patient of vBloc patients in a feasibility study were able to maintain, decrease or

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Page 1: A new approach to weight loss. - MedStar Health · A new approach to weight loss. Mike, vBloc ® Patient of vBloc patients in a feasibility study were able to maintain, decrease or

You’ve been searching for a safer weight loss device

solution that gives you meaningful weight loss without

restricting your food choices and lifestyle. Now it’s here.

A new approach to weight loss.

Mike, vBloc® Patient

of vBloc patients in a feasibility study

were able to maintain, decrease or

discontinue their diabetes medications

while achieving improved glycemic

control at 12 months.3

Improved LDL cholesterol levels

Lowered triglycerides

Lowered blood pressure

Lowered heart rate

Reduced waist circumference

Patients who lost weight with vBloc:4

Patients who used vBloc®

Therapy maintained

their weight loss longer

than those who did not.2

average excess weight loss experienced in one year when vBloc

was used for 12 hours per day1

more weight loss than patients who did not

receive vBloc Therapy2

Effective TreatmentWhat kind of weight loss can you expect?

Meaningful Weight LossLose weight, gain health.

Page 2: A new approach to weight loss. - MedStar Health · A new approach to weight loss. Mike, vBloc ® Patient of vBloc patients in a feasibility study were able to maintain, decrease or

To learn more, visit www.vBloc.com

vBloc related5 serious adverse event rate (SAE)2 Gastric Sleeve Gastric Band Gastric Bypass

0%

10%

20% 13% complication rate6

Surgical complications included all adverse events associated with surgery reported in the studies, such as bleeding, stomal stenosis, leak, vomiting, reflux, gastrointestinal symptoms, and nutritional and electrolyte abnormalities. Reoperation rate was analyzed separately.

13% complication rate6

21% complication rate6

vBloc Therapy is delivered via a pacemaker-like neuroregulator device that blocks hunger signals between the brain

and stomach, making you feel fuller longer and reducing the amount of food you want to eat.

A Safer OptionvBloc Therapy is the safest implanted device for weight loss. Safer than gastric banding.

Trusted TechnologyvBloc Therapy has been studied in

over 600 patients, with some patients

receiving treatment for up to 9 years.

Non-Anatomy AlteringvBloc Therapy does not alter your digestive anatomy. This means your body

continues to process food exactly as it did before, meaning no restrictive/

elimination diets, no potentially embarrassing physical reactions to food

and no life-long nutritional supplement regimens. Enjoy the same foods

as your friends and family without worrying about how your body will react.

Reversible TherapyvBloc Therapy is flexible. If you

need to deactivate or reactivate

for an emergency or pregnancy,

your clinician can do so quickly

and easily. The device can also be

removed at any time.

Minimally Invasive ProcedureThe device is implanted just

under the skin. For many

patients, this can occur in an

outpatient procedure, meaning

less downtime for recovery.

Page 3: A new approach to weight loss. - MedStar Health · A new approach to weight loss. Mike, vBloc ® Patient of vBloc patients in a feasibility study were able to maintain, decrease or

References: 1. Data analysis of 120 patients in the active arm of the ReCharge trial who received 12 hours or more of therapy per day, as directed by the trial protocol. Data on file in PMA P130019 and with EnteroMedics, Inc.

2. Ikrammudin S, et al. ReCharge Trial. JAMA. 2014;312(9):915-922.

3. Shikora S, et al. Vagal blocking improves glycemic control and elevated blood pressure in obese subjects with type 2 diabetes mellitus. J Obes. 2013;2013:245683. doi: 10.1155/2013/245683.

4. PMA P130019 Section 9.2.13.

5. Implant/revision procedure, device, or therapy-related serious adverse event rate at 12 months.

6. Chang S, et al. The effectiveness and risks of bariatric surgery. JAMA Surg. 2014;149(3)275-287.

Patient ambassadors have received consulting compensation.

“It’s almost too simple to say

I’m not as hungry. I have a

mental freedom from food

now and it is so worth it.

It’s a wonderful feeling. I’m

getting help but I’m the one

making the choices.

I’m finally able

to do it.”

Erica, vBloc Patient

BMI of 35 to 39.9 with a health-related condition, such as:

BMI of 40 to 45

Are You a Qualified Patient?You may be a candidate for vBloc Therapy

if you meet these criteria:

OR

Have tried to lose weight by diet and exercise in a supervised program within the last 5 years

Contraindications

Do not have the system implanted if you: have cirrhosis or high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; need magnetic resonance imaging or a diathermy procedure using heat; are at high risk for surgery; or have an implanted electronic device.

Are at least 18 years of age

• High blood pressure

• High cholesterol

• Type 2 diabetes

• Sleep apnea

Page 4: A new approach to weight loss. - MedStar Health · A new approach to weight loss. Mike, vBloc ® Patient of vBloc patients in a feasibility study were able to maintain, decrease or

Important Safety Information Talk with your doctor about the full risks and benefits of vBloc® Therapy and the Maestro® Rechargeable System.

What is the Maestro System Used For: The Maestro System is for use in helping with weight loss in people aged 18 years through age 65 who are obese, with a Body Mass Index (BMI) of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels. Individuals should have first tried to lose weight by diet and exercise in a supervised program within the last 5 years before receiving the Maestro System.

Contraindications: Do not have the system implanted if you: have cirrhosis (a disease of the liver), portal hypertension (high blood pressure in the veins of the liver), esophageal varices (enlarged veins at the lower end of the tube between the mouth and the stomach) or a significant hiatal hernia (a condition where part of the stomach pushes up or through the diaphragm where the tube between the mouth and the stomach passes through to connect to the stomach); need magnetic resonance imaging (a type of medical imaging that uses strong magnets and pulses of radio waves) or diathermy (a type of medical procedure that heats and destroys tissue); are at high risk for surgical complications; or have an implanted electronic medical device.

Warnings/Precautions/Adverse Events: Seek guidance from your doctor before you undergo a medical or surgical procedure, as interaction of the device with certain medical therapies, procedures or other implanted or body worn medical devices may harm you, cause damage to the implanted device or may turn therapy off. These may include, but are not limited to, lithotripsy (use of high energy shock waves to break up stones), radiation, mono polar electrosurgical instruments (a type of surgical instrument), positron emission tomography scans (a type of medical imaging), radiofrequency ablation (a method of destroying tissue used during surgery), heart pacemakers, defibrillators,

neurostimulators, and insulin pumps. Turning, twisting, or manipulating the implanted components may damage the nerves or implanted device. Keep system components charged to prevent damage, which may require surgery to replace the implanted device. The neuroregulator should be fully charged prior to turning it off. The Maestro System is MR Unsafe, including for patients in which the device was explanted and not all components were removed. Portable outlets or extension cords should not be connected to the AC recharger. Do not immerse external system components in fluid. Keep strong magnets at least 6 inches away from the implanted device. The system may activate metal detectors or other security systems. Strong magnetic fields that emit radio frequency signals may interfere with the function of the system. The neuroregulator and mobile charger should be turned off near metal detectors, other security systems, strong magnetic fields and radio frequency emitting systems. The mobile charger should be turned off while aboard aircraft. Infection at the implant site may occur and could require use of antibiotic medications, surgery, or device explant. Do not modify any components of the system. Safety and effectiveness has not been established for use within a hyperbaric chamber (chamber designed to supply oxygen at a higher than normal air pressure), with external defibrillation, during pregnancy, or for use in patients under 18 years of age. The capacity of the rechargeable neuroregulator battery will diminish over time, requiring longer or more frequent charging. Do not operate the system in flammable environments, or if components appear damaged. Do not cover the mobile charger when in use to prevent overheating and damage. You may not be able to operate the system if you have impaired vision. Make sure all of your health care providers are aware that you have an implanted Maestro System.

The most common related adverse events include pain, heartburn, nausea, difficulty swallowing, belching, and abdominal cramping.

Carefully read the product instruction manuals for complete safety information. © 2015 EnteroMedics, Inc. All rights reserved.